To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Company Completes Human Clinical Trials in Russia for Rheumatoid Arthritis URL: http://www.pslgroup.com/dg/CC9A.htm Doctor's Guide October 1, 1996
WOODLAND HILLS, Calif., Oct. 01, 1996 -- Advanced Biotherapy Concepts, Inc., (Nasdaq: ADVB) is a research and development company developing a pioneering treatment for autoimmune diseases. Russian investigators working with Company scientists, have completed clinical trials on twenty adult patients in Russia who suffer from severe rheumatoid arthritis using AGT-1(TM), a combination of antibody preparations directed against certain cytokines. The results demonstrated a striking improvement in patients receiving this therapy. AGT-1(TM) removes or neutralizes the cytokines' alpha interferon, gamma interferon and tumor necrosis factor. These are soluble components of the immune system that are largely responsible for regulating the immune response and inflammation. During certain autoimmune diseases, such as rheumatoid arthritis, these cytokines are overproduced by the human body, disturbing the immune system and leading to disease. The patients were selected from among those with the most severe symptoms of active rheumatoid arthritis who had not responded to conventional therapy. The patients were randomized into four study groups, three receiving individual antibody preparations, and the fourth, a combination of all three antibodies. The trials were conducted under a joint clinical agreement with the Institute of Rheumatology of the Academy of Medical Sciences of the Russian Federation in Moscow. Professor Jakov Sigidin, M.D., Director of the Rheumatology Clinic, and Galina Loukina, M.D., conducted the studies in Russia. Each patient received daily injections of AGT-1(TM) for five consecutive days. A decrease in joint pain and swelling was observed in some patients as early as the first day of treatment. By the end of the first week, all groups not only demonstrated significant improvement in clinical symptoms, including decrease in joint pain, swelling and stiffness, but also showed reduction of disease severity based on certain laboratory measures. The results thus far indicate that removal of a combination of cytokines utilizing AGT-1(TM) was the most effective treatment. These studies represent the first human clinical trials demonstrating that, in addition to alpha interferon and tumor necrosis factor, gamma interferon is a major factor in the development of autoimmune disease. Alpha interferon has been previously demonstrated to play an important role in the exacerbation of autoimmune disease. In addition to these studies, the Company was asked by Professor Igor Reznik, M.D., Director of Clinical Immunology, and Dr. Marina Kuznitsova, M.D., both of the Research Institute for Pediatric Hematology in Moscow, to provide AGT-1(TM) on a "compassionate needs" basis to treat a seven-year old girl suffering from very severe juvenile rheumatoid arthritis. Despite the use of traditional drugs and increased use of non-steroidals, she suffered from fever, severe pain in her wrists and knees, and disabling restriction of her hip joint. Laboratory and x-ray data indicated evidence of inflammation in the affected joints. All previous therapy had been ineffective. Following five days of treatment with AGT-l(TM), significant clinical improvement occurred with normalization of temperature, decrease of morning stiffness, reduction of hip pain, significant increase in the range of motion in the affected joints, improvement in grip strength, and an overall increase in physical activity and quality of life. More significantly, x-rays clearly showed improvement of the affected joints and laboratory measures had normalized in subsequent tests. For a period of six months following initial treatment, the patient has continued to show a lack of disease activity and has regained full mobility. A second patient was also treated with AGT-1(TM) on a compassionate needs basis and showed similar improvement. A 22-year old year old female, diagnosed with ankylosing spondylitis, an autoimmune disease affecting the spinal column, was treated at the Georgetown University Medical Center in Washington D.C. with a five day course of AGT-1(TM). She had previously failed to respond to all forms of conventional rheumatoid therapy. By the end of the first week of therapy, significant improvement in painful joint disease was seen with a reduction of radiating pain and normalization of certain key laboratory measures such as the sedimentation rate, a useful measure of the inflammatory response. The treatment was administered by Dr. Joseph A. Bellanti, Professor of Clinical Immunology and Director of the International Center for Interdisciplinary studies of Immunology at Georgetown. The Company's treatment was developed by Professor Simon Skurkovich, M.D., the first scientist to propose that overproduced interferons may actually trigger autoimmune disease. He was the first to remove these cytokines in patients who suffered from severe rheumatoid arthritis during a period when the scientific community believed that interferons were only beneficial. After publishing his first hypothesis in the journal "Nature" in 1974, other independent experimental studies in the U.S. and Europe involving the removal of interferons in autoimmune disease confirmed his theory. Dr. Skurkovich and his colleagues also developed a preparation against antibiotic resistant bacteria which saved hundreds of thousands of lives in Russia and Eastern Europe. His laboratory received the coveted State Prize for his research. In 1985, a form of AGT-1(TM) was first tested in the U.S. in patients with advanced AIDS, also considered an autoimmune condition, in studies conducted at Georgetown University Medical Center under the direction of Dr. Joseph A. Bellanti. Current evidence suggests that alpha interferon and other cytokines may facilitate the replication of the HIV virus. The overall goal of the treatment was not to directly kill the virus but to remove alpha interferon, which Dr. Skurkovich attributes to the increased survival of the virus in patients with AIDS. Following intramuscular injections of a form of AGT-1(TM), the patients showed marked improvement in weight gain, appetite, sense of well being and a clearing of skin lesions. Recently published reports of independent studies conducted in Europe with AIDS patients, using a vaccine against alpha interferon, have confirmed the Company's approach. In these European studies, AIDS patients from whom alpha interferon was removed experienced no clinical deterioration in health over a 24-30 month period, while a comparable group of patients who did not receive the vaccine experienced clinical deterioration. The Company believes its therapy will prove effective in the treatment of other autoimmune conditions such as systemic lupus erythematosus (SLE) since similar mechanisms may be involved in all such diseases. Various forms of AGT-1(TM), therefore, could become a universal treatment for these diseases. Unlike present medications which provide symptomatic therapy, AGT-1(TM) is directed at the cause of the disease. Later this year, the Company will begin collaborative clinical trials in Russia in patients who suffer from SLE. The Company has expanded its scientific advisory board, which consists of the following internationally renowned scientists: * Dr. Joseph A. Bellanti - Director of the International Center for Interdisciplinary Studies of Immunology at the Georgetown School of Medicine * Dr. Rita Colewell - President of the University of Maryland Biotechnology Institute * Dr. Norman Talal - Autoimmune disease & immunology specialist Discussions are also being held with other well known scientists for consideration as scientific advisors. The Company is also seeking financial and strategic relationships for the development of monoclonal antibodies and commercialization of its science. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.